The British Generic Manufacturers Association (BGMA) has said the UK risks becoming a “backwater” supply market for medicines – potentially jeopardising £18bn of NHS savings from new off-patent drugs in the next five years – unless a more supportive policy environment is introduced.
The BGMA, the representative trade association for off-patent medicines, has launched a manifesto detailing the policy areas where generics and biosimilars - which represent four out of five NHS prescriptions - can be maximised.
Currently, the UK benefits from the lowest medicine prices in Europe. This is due to the competitive generic and biosimilar market, which sees prices paid by the NHS quickly erode by as much as 80% following the patent expiration of an originator product.
This results in the NHS saving over £15bn a year on its budget, enabling more patients to access the medicines they need.
However, despite the success of the off-patent market, there is no dedicated policy framework to support the sector that supplies four out of five medicines.
there's a significant risk that the £18 billion of NHS savings on offer from generics and biosimilars over the next five years will not be realised
Generics or biosimilars are not even mentioned in the current Government’s Life Sciences Vision.
Since the EU-UK Trade and Cooperation Agreement, the UK has had to compete on its own to get stock allocations of medicines from multinational companies operating globally.
This has come when the operating environment has become increasingly challenging for an industry that relies on simplicity for economic growth.
Issues include significant delays via the Medicines and Healthcare products Regulatory Agency (MHRA), a volatile pricing regime, and changes emanating from the EU-UK Trade and Cooperation Agreement that have hurt domestic manufacturing capacity.
The culmination of these issues has seen a doubling in the number of shortages, as manufacturers are finding the UK a commercially unsustainable market to supply.
In the next five years, 255 medicine patents will expire, generating prospective savings to the NHS – based on current market levels of competition in generics and biosimilars – of approximately £18bn. This is on top of the annual savings of £15bn from already patented expired products.
Mark Samuels, CEO of the BGMA, said: “Despite being intrinsic to the health and well-being of our nation, the generic and biosimilar medicine sector has been largely ignored from a policy perspective. The EU-UK Trade and Cooperation Agreement has hurt the UK’s medicines supply resilience, adding regulatory and logistical complexity to an industry that relies on simplicity to survive."
“Our sector supplies the NHS with high volumes of medicines but with razor-thin margins. Throw in a volatile government pricing system over the past five years alongside a doubling of domestic regulatory delays, then the UK is becoming an increasingly unattractive market for international companies."
“The sustained high period of drug shortages we are currently seeing is the evidence of a complacent policy approach to the UK’s off-patent sector."
“With a General Election looming, we urge whoever forms the next Government to create a dedicated and targeted set of policies to support this critical sector's survival and economic growth. Without specific support, there's a significant risk that the £18bn of NHS savings on offer from generics and biosimilars over the next five years will not be realised."
“This will have a detrimental impact on NHS finances and those of the integrated care boards, harming their ability to invest in improved services for patients.”
The BGMA’s manifesto covers four broad policy areas, including:
- How the off-patent sector can save the NHS more money
- Economic and domestic growth to encourage inward investment
- Health and access to medicines and what to do about shortages
- Global partnerships and why intellectual property matters
Within these sections are a range of policy recommendations, including:
- A dedicated national strategy for biosimilars for England.
- The government should use at least half of the £520m announced in the 2023 Autumn Statement to support UK manufacturing of generic and biosimilar medicines and improve security of supply.
- The MHRA must prioritise reducing the generics licensing backlog and fund and commit to a return to most licences being determined within 12 months, with changes to existing licences completed within three months.
- A commitment to protect the NHS from higher medicine prices in post-Brexit trade agreements and, crucially, a push for reciprocity of regulatory decisions worldwide to avoid the UK being a rule-taker.
Mark Samuels added: “Our manifesto lays out a range of areas where real progress could be achieved. These would drive economic growth, restore medicine supply resilience, increase the savings the NHS makes and, importantly, allow more patients to access vital medicines.
“The success of the UK’s off-patent market has long been envied, but the huge progress achieved is being undermined by a policy vacuum that prioritises new medicines only. New treatments are incredibly important, but we cannot ignore the established medicines, which represent the vast majority of prescription products taken every day by patients. We must act to prevent the possibility of the UK becoming a backwater market regarding medicines supply and the consequences that means for us all in accessing vital treatments.”
